US20070219578A1 - Aneurysm coil delivery system - Google Patents
Aneurysm coil delivery system Download PDFInfo
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- US20070219578A1 US20070219578A1 US11/685,807 US68580707A US2007219578A1 US 20070219578 A1 US20070219578 A1 US 20070219578A1 US 68580707 A US68580707 A US 68580707A US 2007219578 A1 US2007219578 A1 US 2007219578A1
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- access
- occlusion
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- distal end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/00296—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1006—Balloons formed between concentric tubes
Definitions
- the present invention relates to devices and methods for treating intracranial aneurysms.
- Current methods for endovascular treatment for such aneurysms include the introduction of coils into the aneurysm to fill or occlude the aneurysm.
- loops of coils may not be contained within the aneurysm and may protrude out into the vessel.
- a known technique to prevent escape of the coils is a two-catheter technique, in which a microcatheter and a balloon catheter are introduced simultaneously.
- the microcatheter is placed within the aneurysm, and, during coil delivery, a balloon is inflated in the parent vessel adjacent to the aneurysm orifice.
- the balloon remains inflated during coil delivery and until the configuration of coils is set, after which the balloon is deflated and the catheter is removed.
- two microcatheters are placed in an aneurysm and multiple coils are introduced.
- An alternative method includes the use of self-expanding stents such as, for example, the NeuroformTM stents manufactured by Boston Scientific Corp. (MA, USA). Specifically, such stents are presented to the site of the aneurysm and deployed, and can help to prevent escape of coils. Self expanding stents are generally used due to their low profile and maneuverability, features which are crucial for small vessels associated with intracranial aneurysms. However, they are prone to positioning problems and are difficult to anchor in place during deployment.
- stents in general is not always considered optimal, since once the stent is in place, it cannot be removed and may itself present additional problems such as turbulence, thrombosis, or even stenosis in the stented region of the vessel. Moreover, the presence of a stent warrants patient-prescribed anti-coagulation medication, which may be contraindicated for some patients.
- a device for providing a coil to an aneurysm includes an access element having an access lumen and a distal end which is pre-shaped at an angle to a longitudinal axis of the device and which may be forcibly aligned with the longitudinal axis, and an occlusion element for occluding an ostium of the aneurysm during delivery of the coil, the occlusion element at least partially attached to the access element.
- a method for treating an aneurysm includes providing a device having an access element and an occlusion element, the access element having a distal end which includes a pre-shaped configuration which is at an angle to a longitudinal axis of the device, providing a guidewire through the access element and a distal connecting element positioned at a distal end of the occlusion element so as to straighten the pre-shaped distal end, introducing the device into a vessel adjacent to the aneurysm; releasing the guidewire from the distal connecting element so as to cause the access element to assume its pre-shaped configuration, occluding an ostium of the aneurysm the said occlusion element, and delivering a coil through the access element and into the aneurysm.
- FIGS. 1A and 1B are schematic illustrations of a device in accordance with embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively;
- FIGS. 1C , 1 D and 1 E are cross-sectional illustrations of the device of FIGS. 1A and 1B , showing an access lumen, an inflation lumen and a core wire, in accordance with several configurations;
- FIGS. 1F and 1G are illustrations of a distal portion of the device of FIGS. 1A and 1B in accordance with additional embodiments of the present invention.
- FIGS. 2A and 2B are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively;
- FIG. 2C is a cross-section illustration of the device of FIGS. 2A and 2B , showing an access lumen, an inflation lumen coaxial to the access lumen, and a core wire;
- FIGS. 3A and 3B are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively;
- FIG. 3C is a cross-section illustration of the device of FIGS. 3A and 3B , showing an access lumen, a shaft and a core wire;
- FIGS. 4A and 4B are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a pre-deployed state and in a deployed state, respectively;
- FIGS. 5A-5D are schematic illustrations of a device in accordance with yet further embodiments of the present invention, shown in deployed states in FIGS. 5A and 5C and in pre-deployed states in FIGS. 5B and 5D ;
- FIGS. 6A-6D are schematic illustrations of the steps of a method of using the devices of FIGS. 1A-1G or FIGS. 2A-2C , in accordance with embodiments of the present invention.
- FIGS. 7A-7D are schematic illustrations of the steps of a method of using the devices of FIGS. 3A-3C , in accordance with embodiments of the present invention.
- FIGS. 8A-8D are schematic illustrations of the steps of a method of using the devices of FIGS. 5A-5D , in accordance with embodiments of the present invention.
- FIGS. 9A-9C are schematic illustrations of the steps of a method of using the devices of the present application to treat an aneurysm at a Y-bifurcation;
- FIGS. 10A-10C are schematic illustrations of the steps of a method of using the device of FIGS. 4A and 4B to treat an aneurysm at a Y-bifurcation;
- FIGS. 11A-11C are schematic illustrations of views of marker positions in accordance with several different positions of the devices of the present invention.
- FIGS. 1A and 1B are schematic illustrations of a device 100 in accordance with embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively.
- Device 100 includes a shaft 103 having a proximal end 102 and a distal portion 104 .
- Shaft 103 is comprised of an access element 106 for accessing an area of an aneurysm, and an occlusion element 110 , for providing occlusion means to the ostium of the aneurysm.
- Distal portion 104 of shaft 103 includes an access element distal portion 107 and an occlusion element distal portion 140 , wherein occlusion element distal portion 140 includes a balloon 116 having a balloon proximal end 142 and a balloon distal end 144 .
- access element 106 is an elongated element extending from proximal end 102 of shaft 103 to distal portion 104 of shaft 103 , and includes an access lumen 108 therethrough.
- Proximal end 102 of shaft 103 includes an access hub 117 for introduction of a material or object through access lumen 108 .
- Distal portion 107 of access element 106 extends distally past balloon proximal end 142 , and is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material.
- distal portion 107 of access element 106 includes a spring-element that provides pre-shaping.
- a radiopaque access marker 125 is positioned on distal portion 107 of access element 106 .
- Occlusion element 110 is also an elongated element positioned alongside access element 106 and extending from proximal end 102 of shaft 103 to distal portion 104 of shaft 103 .
- Occlusion element 110 has a balloon 116 at a distal end thereof.
- Balloon 116 is shown in an inflated state in FIG. 1A and in a deflated state in FIG. 1B .
- An inflation lumen 112 provides fluid communication between an inflation port 115 at proximal end 102 of shaft 103 and balloon 116 .
- Additional radiopaque markers 124 are positioned along occlusion element 110 and/or shaft 103 .
- a distal connecting element 114 is positioned at the distal end of device 100 , and may be attached to balloon 116 .
- distal connecting element 114 may be attached to a distal tip 119 , distal to balloon 116 , as shown in FIGS. 1F and 1G , in the inflated and deflated states, respectively.
- a radiopaque marker 124 may be positioned on distal connecting element 114 .
- distal portion 107 of access element 106 is pre-shaped at an angle to a longitudinal axis 146 of device 100 , wherein longitudinal axis 146 is defined by an imaginary line connecting distal portion 104 and proximal end 102 of shaft 103 .
- the angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees.
- pre-shaped access element 106 can be forcibly aligned with longitudinal axis 146 of device 100 by placing a guidewire 118 therethrough and further positioning guidewire 118 through distal connecting element 114 .
- This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels.
- access element 106 acts as a microcatheter for providing treatment coils.
- access element 106 acts as a conduit for a separate microcatheter placed therein.
- FIG. 1C is a cross-section illustration of section A-A, showing access lumen 108 and inflation lumen 112 .
- Inflation lumen 112 may be smaller than access lumen 108 , and may assume various shapes and configurations, provided that there is sufficient area for introduction of an inflation fluid.
- the cross-sectional shape of shaft 103 may be approximately circular, as shown in FIG. 1C , elliptical, as shown in FIG. 1D , may assume a figure-eight configuration, as shown in FIG. 1E , or may be any other suitable shape or configuration.
- a core wire 122 is positioned through device 100 to provide stiffness and enhance pushability and trackability. Additionally, stiffness of proximal end 102 of shaft 103 may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability.
- FIGS. 2A and 2B are schematic illustrations of a device 200 in accordance with alternative embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively.
- Device 200 includes a shaft 203 having a proximal end 202 and a distal end 204 .
- Device 200 includes an access element 206 for accessing an area of an aneurysm, and an occlusion element 210 , for providing occlusion means to the ostium of the aneurysm.
- Distal end 204 of shaft 203 includes an access element distal portion 207 and an occlusion element distal portion 240 , wherein occlusion element distal portion 240 includes a balloon 216 having a balloon proximal end 242 and a balloon distal end 244 .
- access element 206 is an elongated element extending from proximal end 202 of shaft 203 to distal end 204 of shaft 203 , and includes an access lumen 208 therethrough.
- Proximal end 202 of shaft 203 includes an access hub 217 for introduction of a material or object through access lumen 208 .
- Distal portion 207 of access element 206 extends distally past balloon proximal end 242 and is comprised of an elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material.
- distal portion 207 of access element 206 includes a spring-element that provides pre-shaping.
- a radiopaque access marker 225 is positioned on distal portion 207 of access element 206 .
- Occlusion element 210 is also an elongated element positioned coaxial to access element 206 and extending from proximal end 202 of shaft 203 to distal end 204 of shaft 203 .
- Occlusion element 210 has a balloon 216 at a distal end thereof.
- Balloon 216 is shown in an inflated state in FIG. 2A and in a deflated state in FIG. 2B .
- An inflation lumen 212 provides fluid communication between an inflation port 215 at proximal end 202 of shaft 203 and balloon 216 .
- Distal portion 207 of access element 206 protrudes through a portion of balloon 216 .
- Additional radiopaque markers 224 are positioned along occlusion element 210 and/or shaft 203 .
- a distal connecting element 214 is positioned at a distal end of device 200 , and may be attached to balloon 216 . Alternatively, distal connecting element 214 may be attached to a distal tip, distal to balloon 216 . As shown in FIG. 2A , distal portion 207 of access element 206 is pre-shaped at an angle to a longitudinal axis 246 of device 200 , wherein longitudinal axis 246 is defined by an imaginary line connecting distal end 204 and proximal end 202 of shaft 203 . The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees.
- pre-shaped access element 206 can be forcibly aligned with longitudinal axis 246 of device 200 by placing a guidewire 218 therethrough and further positioning guidewire 218 through distal connecting element 214 .
- This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels.
- access element 206 acts as a microcatheter for providing treatment coils.
- access element 206 acts as a conduit for a separate microcatheter placed therein.
- FIG. 2C is a cross-section illustration of section B-B, showing access lumen 208 and inflation lumen 212 in a position which is coaxial to access lumen 208 .
- the cross-sectional shape of shaft 203 may be approximately circular, as shown in FIG. 2C , or may be elliptical, may assume a figure-eight configuration, or may be any other suitable shape or configuration.
- a core wire 222 is positioned through device 200 and alongside access element 206 to provide stiffness. Additionally, stiffness of proximal end 202 of shaft 203 may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability.
- FIGS. 3A and 3B are schematic illustrations of a device 300 in accordance with embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively.
- Device 300 includes a shaft 303 having a proximal end 302 and a distal end 304 .
- Device 300 includes an access element 306 for accessing an area of an aneurysm, and an occlusion element 310 , for providing occlusion means to the ostium of the aneurysm.
- Distal end 304 of device 300 includes an access element distal portion 307 and an occlusion element distal portion 340 , wherein occlusion element distal portion 340 includes a balloon 316 having a balloon proximal end 342 and a balloon distal end 344 .
- access element 306 is an elongated element extending distally past balloon proximal end 342 , and includes an access lumen 308 therethrough.
- Access element 306 is comprised of an elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material.
- distal portion 207 of access element 206 includes a spring-element that provides pre-shaping.
- a radiopaque access marker 325 is positioned on distal portion 307 of access element 306 .
- Proximal end 302 of shaft 303 has a larger diameter than distal portion 304 of shaft 303 and than access element 306 .
- Occlusion element 310 is a balloon 316 positioned at distal end 304 of shaft 303 . Both access lumen 308 and balloon 316 are in communication with shaft 303 , and may be accessed via a shared hub 317 .
- Balloon 316 is shown in an inflated state in FIG. 3A and in a deflated state in FIG. 3B .
- a divider 309 partially separates balloon 316 from shaft 303 , allowing fluid flow but not allowing transfer of denser materials.
- This configuration allows for a microcatheter having an outer diameter which is approximately equal to an inner diameter of access element 306 to be introduced through access lumen 308 , effectively sealing access element 306 .
- inflation fluid can be introduced through shaft 303 , and will flow directly into balloon 316 .
- Additional radiopaque markers 324 are positioned along occlusion element 310 and/or shaft 303 .
- a distal connecting element 314 is positioned at a distal end of device 300 , and may be attached to balloon 316 . Alternatively, distal connecting element 314 may be attached to a distal tip, distal to balloon 316 . As shown in FIG. 3A , access element 306 is pre-shaped at an angle to a longitudinal axis 346 of device 300 , wherein longitudinal axis 346 is defined by an imaginary line connecting distal end 304 and proximal end 302 of shaft 303 . The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees.
- pre-shaped access element 306 can be forcibly aligned with longitudinal axis 346 of device 300 by placing a guidewire 318 therethrough and further positioning guidewire 318 through distal connecting element 314 .
- This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels.
- access element 306 acts as a microcatheter for providing treatment coils.
- access element 306 acts as a conduit for a separate microcatheter placed therein.
- FIG. 3C is a cross-section illustration of section C-C showing access lumen 308 and shaft 303 .
- the cross-sectional shape of shaft 303 may be approximately circular, as shown in FIG. 3C , or may be elliptical, may assume a figure-eight configuration, or may be any other suitable shape or configuration.
- a core wire 322 is positioned through device 300 to provide stiffness.
- stiffness of proximal end 302 of shaft 303 may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability.
- FIGS. 4A and 4B are schematic illustrations of a device 400 in accordance with embodiments of the present invention, shown in a pre-deployed state and in a deployed state, respectively.
- Device 400 includes a shaft 403 having a proximal end 402 and a distal end 404 .
- Device 400 includes an access element 406 for accessing an area of an aneurysm, and an occlusion element 410 , for providing occlusion means to the ostium of the aneurysm.
- an access element 406 for accessing an area of an aneurysm
- an occlusion element 410 for providing occlusion means to the ostium of the aneurysm.
- access element 406 is an elongated element extending from an access port 411 along a body of device 400 to distal end 404 of shaft 403 , and includes an access lumen 408 therethrough.
- a radiopaque access marker 425 is positioned on a distal portion of access element 406 .
- Occlusion element 410 is an elongated element extending from proximal end 402 of shaft 403 to a location proximal to distal end 404 of shaft 403 .
- Occlusion element 410 includes a balloon 416 having a distal portion 417 and a proximal portion 418 .
- Distal portion 417 has a different compliance than proximal portion 418 .
- the difference in compliance may be provided by the use of different materials for distal portion 417 and proximal portion 418 .
- the same material may be used, but with different durometers or thicknesses. Any other known method of providing an object with two different compliances may be used.
- distal portion 417 has a lower compliance than proximal portion 418 .
- distal portion 417 has a higher compliance than proximal portion 418 .
- Balloon 416 is shown in a deflated state in FIG. 4A and in an inflated state in FIG. 4B .
- An inflation lumen 412 provides fluid communication between an inflation port 415 at proximal end 402 of shaft 403 and balloon 416 .
- a stent may be positioned at a distal end of any of the devices described above, and that balloon 116 , 216 or 316 may be used to deploy the stent.
- a fixed wire is added to the distal end of balloon 116 , 216 , 316 or to a distal tip of the device. This wire can aid in rotation of the device and can enhance torqueability.
- FIGS. 5A , 5 B, 5 C and 5 D are schematic illustrations of a device 500 in accordance with embodiments of the present invention.
- device 500 in a first embodiment, shown in FIG. 5A in a deployed state and in FIG. 5B in a pre-deployed state, device 500 includes a shaft 503 having a proximal end 502 and a distal portion 504 .
- Device 500 includes an access element 506 for accessing an area of an aneurysm, and an occlusion element 510 , for providing occlusion means to the aneurysm.
- Access element 506 is an elongated element extending from proximal end 502 of shaft 503 to distal portion 504 of shaft 503 , and includes an access lumen 508 therethrough.
- a distal portion 507 of access element 506 is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material.
- distal portion 507 of access element 506 includes a spring-element that provides pre-shaping.
- a radiopaque access marker 525 is positioned on distal portion 507 of access element 506 .
- Occlusion element 510 is also an elongated element positioned alongside and attached to access element 506 , and extending from proximal end 502 of shaft 503 to distal portion 504 of shaft 503 .
- Occlusion element 510 includes an occlusion lumen 512 for introduction of occlusion material, such as a coil, therethrough.
- a distal portion 513 of occlusion element 510 is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material.
- distal portion 513 of occlusion element 510 includes a spring-element that provides pre-shaping. Additional radiopaque markers 524 may be positioned along occlusion element 510 .
- shaft 503 is a dual lumen shaft having an access lumen 508 and an occlusion lumen 512 .
- Distal portions 507 and 513 are pre-shaped at an angle to a longitudinal axis of device 500 , wherein the longitudinal axis is defined by an imaginary line connecting distal portion 504 and proximal end 502 of shaft 503 .
- the angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees.
- Proximal end 502 of shaft 503 includes an access hub 517 for introduction of a material or object through access lumen 508 , and an occlusion hub 519 for introduction of a material or object through occlusion lumen 512 .
- Device 500 is shown in a pre-deployed position in FIG. 5B , wherein a guidewire 518 positioned through occlusion lumen 512 forcibly aligns distal portions 507 and 513 with the longitudinal axis of device 500 .
- guidewire 518 may be positioned through access lumen 508 . This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels.
- distal ends 507 and 513 assume their pre-shaped configuration.
- a distal connecting element 514 is positioned at distal end of occlusion element 510 .
- an additional radiopaque marker 524 may be positioned on distal connecting element 514 .
- pre-shaped access element 506 and pre-shaped occlusion element 510 can be forcibly aligned with the longitudinal axis of device 500 by placing a guidewire 518 through access lumen 508 and further positioning guidewire 518 through distal connecting element 514 .
- FIGS. 6A-6D are schematic illustrations of the steps of a method of using device 100 to treat an aneurysm. Although the figures are shown and described with respect to device 100 , the method for using device 200 may be the same as for device 100 .
- device 100 is introduced over a guidewire 118 into a main vessel 132 to an area of an aneurysm 134 .
- Device 100 is in its unexpanded state, with distal portion 107 of access element 106 held in an aligned position with device 100 via guidewire 118 placed through access element 106 and distal connecting element 114 . As shown in FIG.
- guidewire 118 is retracted proximally, releasing guidewire 118 from distal connecting element 114 , and causing distal portion 107 of access element 106 to assume its pre-shaped configuration.
- Distal portion 107 of access element 106 is positioned within aneurysm 134 .
- Markers 124 and 125 are used for positioning, as will be described in further detail hereinbelow.
- access element 106 is positioned within aneurysm 134 , and balloon 116 is expanded—blocking the neck or ostium of aneurysm 134 .
- FIG. 6C As shown in FIG. 6C , access element 106 is positioned within aneurysm 134 , and balloon 116 is expanded—blocking the neck or ostium of aneurysm 134 .
- a coil 136 is then introduced through access lumen 108 and into aneurysm 134 , in accordance with methods known in the art.
- a microcatheter is then introduced through access lumen 108 , and coil 136 is delivered through the microcatheter.
- Balloon 116 can be inflated and deflated several times during the procedure so as to alternate between allowing normal blood passage through main vessel 132 , and keeping the ostium of aneurysm 134 blocked until coil 136 is set. Once coil 136 is set, balloon 116 is deflated, and device 100 is removed from the vessel.
- FIGS. 7A-7D are schematic illustrations of the steps of a method of using device 300 to treat an aneurysm.
- device 300 is introduced over a guidewire 318 into a main vessel 132 to an area of an aneurysm 134 .
- Device 300 is in its unexpanded state, with access element 306 held in an aligned position with device 300 via guidewire 318 placed through access element 306 and distal connecting element 314 .
- guidewire 318 is retracted proximally, releasing guidewire 318 from distal connecting element 314 , and causing distal portion 307 of access element 306 to assume its pre-shaped configuration.
- Distal portion 307 of access element 306 is positioned within aneurysm 134 . Markers are used for positioning, as will be described in further detail hereinbelow. As shown in FIG. 7C , distal portion 307 of access element 306 is positioned within aneurysm 134 . Microcatheter 320 is then positioned in access lumen 308 . Microcatheter 320 effectively seals access element 306 , allowing for inflation fluid to reach balloon 316 . Balloon 316 is then expanded, blocking the neck or ostium of aneurysm 134 . As shown in FIG. 7D , a coil 336 is then introduced through microcatheter 320 and into aneurysm 134 , in accordance with methods known in the art.
- Balloon 316 can be inflated and deflated several times during the procedure so as to alternate between allowing normal blood passage through main vessel 132 , and keeping the ostium of aneurysm 134 blocked until coil 336 is set. Once coil 336 is set, balloon 316 is deflated, and device 300 is removed from the vessel.
- FIGS. 8A-8D are schematic illustrations of the steps of a method of using device 500 to treat an aneurysm.
- device 500 is introduced over a guidewire 518 into a main vessel 132 to an area of an aneurysm 134 .
- Device 500 is in its undeployed state, with access element 506 and occlusion element 510 held in an aligned position via guidewire 518 placed through access element 506 and distal connecting element 514 .
- FIG. 8A device 500 is introduced over a guidewire 518 into a main vessel 132 to an area of an aneurysm 134 .
- Device 500 is in its undeployed state, with access element 506 and occlusion element 510 held in an aligned position via guidewire 518 placed through access element 506 and distal connecting element 514 .
- FIG. 8A device 500 is introduced over a guidewire 518 into a main vessel 132 to an area of an aneurysm 134 .
- guidewire 518 is retracted proximally, releasing guidewire 518 from distal connecting element 514 , and causing distal portion 507 of access element 506 and distal portion 513 of occlusion element 510 to assume their pre-shaped configurations.
- Distal portion 507 of access element 506 and distal portion 513 of occlusion element 510 are positioned within aneurysm 134 .
- Markers 524 and 525 are used for positioning, as will be described in further detail hereinbelow.
- a blocking coil 535 is introduced through occlusion lumen 512 and into aneurysm 134 —blocking the neck or ostium of aneurysm 134 .
- FIG. 8C a blocking coil 535 is introduced through occlusion lumen 512 and into aneurysm 134 —blocking the neck or ostium of aneurysm 134 .
- one or more coils 136 are then introduced through access lumen 508 and into aneurysm 134 , in accordance with methods known in the art. After coils 136 are delivered into aneurysm 134 and detached, and satisfactory filling of the aneurysm is confirmed, blocking coil 535 is detached. Detachment of coils 136 and blocking coil 535 is achieved in accordance with methods known in the art. Alternatively, a microcatheter is introduced through occlusion lumen 512 to deliver blocking coil 535 , and a microcatheter is introduced through access lumen 108 to deliver coils 136 . This method alleviates the long occlusion time or potential vessel damage sometimes associated with the use of balloons for occlusion.
- FIGS. 9A-9C are schematic illustrations of a method of using device 100 to treat an aneurysm at a Y-bifurcation, such as a vertebrobasilar junction.
- an aneurysm 234 may be positioned just opposite a main vessel 232 , and must be accessed head-on rather than from an angle.
- FIG. 9A device 100 is introduced over a guidewire 118 through main vessel 232 .
- access element 106 is positioned in aneurysm 134 .
- Balloon 116 is then inflated, as shown in FIG. 9C .
- balloon 116 is compliant enough to block the ostium on its own.
- coil 136 is introduced into aneurysm 134 , as described above with respect to FIGS. 6A-6D , 7 A- 7 D and 8 A- 8 D.
- FIGS. 10A-10C are schematic illustrations of a method of using device 400 to treat an aneurysm at a Y-bifurcation, such as a vertebrobasilar junction.
- an aneurysm 234 may be positioned just opposite a main vessel 232 , and must be accessed head-on rather than from an angle.
- device 400 is introduced over a guidewire 419 through main vessel 232 .
- access element 406 is positioned in aneurysm 134 , and balloon 416 is inflated.
- proximal portion 418 causes proximal portion 417 to be inflated over a wide area, causing the ostium to be substantially blocked.
- the low compliance of distal portion 417 prevents balloon 416 from expanding into aneurysm 234 .
- coil 136 is introduced into aneurysm 234 , as described above with respect to FIGS. 6A-6D , 7 A- 7 D, 8 A- 8 D, and 9 A- 9 D.
- FIGS. 11A , 11 B and 11 C are illustrations of several views of marker positioning.
- Marker 125 positioned on distal portion 107 of access element 106 , and markers 124 , positioned along the longitudinal axis of device 100 , together provide an indication of positioning and location. It should be readily apparent that similar configurations are provided in the alternative embodiments of device 200 , 300 , 400 , and 500 .
- markers 124 form a relatively straight line, while marker 125 is slightly off the line formed by markers 124 . This indicates translational positioning of device 100 prior to deployment.
- the distal portion 107 of access element 106 of device 100 When the distal portion 107 of access element 106 of device 100 is released, it assumes its pre-shaped configuration, and marker 125 moves to a position which is further off the line formed by markers 124 , as shown in FIG. 11B . If positioning is inaccurate, marker 125 appears at a side opposite the aneurysm, as shown in FIG. 11C . Thus, if a user views the view shown in FIG. 11C or a similar view, the user can then rotate device 100 until it is in the correct position as indicated by the position of markers 124 and 125 as shown in FIG. 11B . This specific configuration of markers allows for proper alignment and positioning within the vessel.
- access element 106 , 206 , 306 , 406 or 506 may include multiple access lumens. Moreover, points of attachment of access element 106 , 206 , 306 or 506 to occlusion element 110 , 210 , 310 or 510 , respectively, may vary. In one embodiment, the access element is attached at a midpoint of the balloon. In other embodiments, the access element is attached at a proximal end of the balloon, at a distal end of the balloon, or at any point in between.
Abstract
Description
- The present invention relates to devices and methods for treating intracranial aneurysms. Treatment of various types of intracranial aneurysms, such as wide-neck and vertebrobasilar aneurysms, has been particularly difficult. Current methods for endovascular treatment for such aneurysms include the introduction of coils into the aneurysm to fill or occlude the aneurysm. However, particularly in cases of wide-neck aneurysm, loops of coils may not be contained within the aneurysm and may protrude out into the vessel. A known technique to prevent escape of the coils is a two-catheter technique, in which a microcatheter and a balloon catheter are introduced simultaneously. For example, in one technique, the microcatheter is placed within the aneurysm, and, during coil delivery, a balloon is inflated in the parent vessel adjacent to the aneurysm orifice. The balloon remains inflated during coil delivery and until the configuration of coils is set, after which the balloon is deflated and the catheter is removed. In another technique, two microcatheters are placed in an aneurysm and multiple coils are introduced.
- The use of two devices is cumbersome and can result in wire entanglement, limited pushability and torqueability, increased procedure time and complications.
- An alternative method includes the use of self-expanding stents such as, for example, the Neuroform™ stents manufactured by Boston Scientific Corp. (MA, USA). Specifically, such stents are presented to the site of the aneurysm and deployed, and can help to prevent escape of coils. Self expanding stents are generally used due to their low profile and maneuverability, features which are crucial for small vessels associated with intracranial aneurysms. However, they are prone to positioning problems and are difficult to anchor in place during deployment. Furthermore, the use of stents in general is not always considered optimal, since once the stent is in place, it cannot be removed and may itself present additional problems such as turbulence, thrombosis, or even stenosis in the stented region of the vessel. Moreover, the presence of a stent warrants patient-prescribed anti-coagulation medication, which may be contraindicated for some patients.
- It would thus be advantageous to have a device which could be used to prevent escape of coils during a procedure which is devoid of the above limitations.
- According to one aspect of the invention, there is provided a device for providing a coil to an aneurysm. The device includes an access element having an access lumen and a distal end which is pre-shaped at an angle to a longitudinal axis of the device and which may be forcibly aligned with the longitudinal axis, and an occlusion element for occluding an ostium of the aneurysm during delivery of the coil, the occlusion element at least partially attached to the access element.
- According to another aspect of the invention, there is provided a method for treating an aneurysm. The method includes providing a device having an access element and an occlusion element, the access element having a distal end which includes a pre-shaped configuration which is at an angle to a longitudinal axis of the device, providing a guidewire through the access element and a distal connecting element positioned at a distal end of the occlusion element so as to straighten the pre-shaped distal end, introducing the device into a vessel adjacent to the aneurysm; releasing the guidewire from the distal connecting element so as to cause the access element to assume its pre-shaped configuration, occluding an ostium of the aneurysm the said occlusion element, and delivering a coil through the access element and into the aneurysm.
- Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
- The above and further advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which:
-
FIGS. 1A and 1B are schematic illustrations of a device in accordance with embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively; -
FIGS. 1C , 1D and 1E are cross-sectional illustrations of the device ofFIGS. 1A and 1B , showing an access lumen, an inflation lumen and a core wire, in accordance with several configurations; -
FIGS. 1F and 1G are illustrations of a distal portion of the device ofFIGS. 1A and 1B in accordance with additional embodiments of the present invention; -
FIGS. 2A and 2B are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively; -
FIG. 2C is a cross-section illustration of the device ofFIGS. 2A and 2B , showing an access lumen, an inflation lumen coaxial to the access lumen, and a core wire; -
FIGS. 3A and 3B are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively; -
FIG. 3C is a cross-section illustration of the device ofFIGS. 3A and 3B , showing an access lumen, a shaft and a core wire; -
FIGS. 4A and 4B are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a pre-deployed state and in a deployed state, respectively; -
FIGS. 5A-5D are schematic illustrations of a device in accordance with yet further embodiments of the present invention, shown in deployed states inFIGS. 5A and 5C and in pre-deployed states inFIGS. 5B and 5D ; -
FIGS. 6A-6D are schematic illustrations of the steps of a method of using the devices ofFIGS. 1A-1G orFIGS. 2A-2C , in accordance with embodiments of the present invention; -
FIGS. 7A-7D are schematic illustrations of the steps of a method of using the devices ofFIGS. 3A-3C , in accordance with embodiments of the present invention; -
FIGS. 8A-8D are schematic illustrations of the steps of a method of using the devices ofFIGS. 5A-5D , in accordance with embodiments of the present invention; -
FIGS. 9A-9C are schematic illustrations of the steps of a method of using the devices of the present application to treat an aneurysm at a Y-bifurcation; -
FIGS. 10A-10C are schematic illustrations of the steps of a method of using the device ofFIGS. 4A and 4B to treat an aneurysm at a Y-bifurcation; and -
FIGS. 11A-11C are schematic illustrations of views of marker positions in accordance with several different positions of the devices of the present invention. - It will be appreciated that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been drawn accurately or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity or several physical components may be included in one functional block or element. Further, where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function.
- In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. It will be understood by those of ordinary skill in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components and structures may not have been described in detail so as not to obscure the present invention.
- Reference is now made to
FIGS. 1A and 1B , which are schematic illustrations of adevice 100 in accordance with embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively.Device 100 includes ashaft 103 having aproximal end 102 and adistal portion 104.Shaft 103 is comprised of anaccess element 106 for accessing an area of an aneurysm, and anocclusion element 110, for providing occlusion means to the ostium of the aneurysm.Distal portion 104 ofshaft 103 includes an access elementdistal portion 107 and an occlusion elementdistal portion 140, wherein occlusion elementdistal portion 140 includes aballoon 116 having a balloonproximal end 142 and a balloondistal end 144. In the embodiment shown inFIGS. 1A and 1B ,access element 106 is an elongated element extending fromproximal end 102 ofshaft 103 todistal portion 104 ofshaft 103, and includes anaccess lumen 108 therethrough.Proximal end 102 ofshaft 103 includes anaccess hub 117 for introduction of a material or object throughaccess lumen 108.Distal portion 107 ofaccess element 106 extends distally past balloonproximal end 142, and is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively,distal portion 107 ofaccess element 106 includes a spring-element that provides pre-shaping. Aradiopaque access marker 125 is positioned ondistal portion 107 ofaccess element 106.Occlusion element 110 is also an elongated element positioned alongsideaccess element 106 and extending fromproximal end 102 ofshaft 103 todistal portion 104 ofshaft 103.Occlusion element 110 has aballoon 116 at a distal end thereof.Balloon 116 is shown in an inflated state inFIG. 1A and in a deflated state inFIG. 1B . Aninflation lumen 112 provides fluid communication between aninflation port 115 atproximal end 102 ofshaft 103 andballoon 116. Additionalradiopaque markers 124 are positioned alongocclusion element 110 and/orshaft 103. - A distal connecting
element 114 is positioned at the distal end ofdevice 100, and may be attached toballoon 116. Alternatively, distal connectingelement 114 may be attached to adistal tip 119, distal toballoon 116, as shown inFIGS. 1F and 1G , in the inflated and deflated states, respectively. In this embodiment, aradiopaque marker 124 may be positioned on distal connectingelement 114. As shown inFIG. 1A ,distal portion 107 ofaccess element 106 is pre-shaped at an angle to alongitudinal axis 146 ofdevice 100, whereinlongitudinal axis 146 is defined by an imaginary line connectingdistal portion 104 andproximal end 102 ofshaft 103. The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. - As shown in
FIG. 1B ,pre-shaped access element 106 can be forcibly aligned withlongitudinal axis 146 ofdevice 100 by placing aguidewire 118 therethrough andfurther positioning guidewire 118 through distal connectingelement 114. This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. In one embodiment,access element 106 acts as a microcatheter for providing treatment coils. In an alternative embodiment,access element 106 acts as a conduit for a separate microcatheter placed therein. - Reference is now made to
FIG. 1C , which is a cross-section illustration of section A-A, showingaccess lumen 108 andinflation lumen 112.Inflation lumen 112 may be smaller thanaccess lumen 108, and may assume various shapes and configurations, provided that there is sufficient area for introduction of an inflation fluid. The cross-sectional shape ofshaft 103 may be approximately circular, as shown inFIG. 1C , elliptical, as shown inFIG. 1D , may assume a figure-eight configuration, as shown inFIG. 1E , or may be any other suitable shape or configuration. In some embodiments, acore wire 122 is positioned throughdevice 100 to provide stiffness and enhance pushability and trackability. Additionally, stiffness ofproximal end 102 ofshaft 103 may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability. - Reference is now made to
FIGS. 2A and 2B , which are schematic illustrations of adevice 200 in accordance with alternative embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively.Device 200 includes ashaft 203 having aproximal end 202 and adistal end 204.Device 200 includes an access element 206 for accessing an area of an aneurysm, and anocclusion element 210, for providing occlusion means to the ostium of the aneurysm.Distal end 204 ofshaft 203 includes an access elementdistal portion 207 and an occlusion elementdistal portion 240, wherein occlusion elementdistal portion 240 includes aballoon 216 having a balloonproximal end 242 and a balloondistal end 244. In the embodiment shown inFIGS. 2A and 2B , access element 206 is an elongated element extending fromproximal end 202 ofshaft 203 todistal end 204 ofshaft 203, and includes anaccess lumen 208 therethrough.Proximal end 202 ofshaft 203 includes anaccess hub 217 for introduction of a material or object throughaccess lumen 208.Distal portion 207 of access element 206 extends distally past balloonproximal end 242 and is comprised of an elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively,distal portion 207 of access element 206 includes a spring-element that provides pre-shaping. Aradiopaque access marker 225 is positioned ondistal portion 207 of access element 206.Occlusion element 210 is also an elongated element positioned coaxial to access element 206 and extending fromproximal end 202 ofshaft 203 todistal end 204 ofshaft 203.Occlusion element 210 has aballoon 216 at a distal end thereof.Balloon 216 is shown in an inflated state inFIG. 2A and in a deflated state inFIG. 2B . Aninflation lumen 212 provides fluid communication between aninflation port 215 atproximal end 202 ofshaft 203 andballoon 216.Distal portion 207 of access element 206 protrudes through a portion ofballoon 216. Additionalradiopaque markers 224 are positioned alongocclusion element 210 and/orshaft 203. - A distal connecting
element 214 is positioned at a distal end ofdevice 200, and may be attached toballoon 216. Alternatively, distal connectingelement 214 may be attached to a distal tip, distal toballoon 216. As shown inFIG. 2A ,distal portion 207 of access element 206 is pre-shaped at an angle to alongitudinal axis 246 ofdevice 200, whereinlongitudinal axis 246 is defined by an imaginary line connectingdistal end 204 andproximal end 202 ofshaft 203. The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. - As shown in
FIG. 2B , pre-shaped access element 206 can be forcibly aligned withlongitudinal axis 246 ofdevice 200 by placing aguidewire 218 therethrough andfurther positioning guidewire 218 through distal connectingelement 214. This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. In one embodiment, access element 206 acts as a microcatheter for providing treatment coils. In an alternative embodiment, access element 206 acts as a conduit for a separate microcatheter placed therein. - Reference is now made to
FIG. 2C , which is a cross-section illustration of section B-B, showingaccess lumen 208 andinflation lumen 212 in a position which is coaxial to accesslumen 208. The cross-sectional shape ofshaft 203 may be approximately circular, as shown inFIG. 2C , or may be elliptical, may assume a figure-eight configuration, or may be any other suitable shape or configuration. In some embodiments, acore wire 222 is positioned throughdevice 200 and alongside access element 206 to provide stiffness. Additionally, stiffness ofproximal end 202 ofshaft 203 may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability. - Reference is now made to
FIGS. 3A and 3B , which are schematic illustrations of adevice 300 in accordance with embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively.Device 300 includes ashaft 303 having aproximal end 302 and adistal end 304.Device 300 includes anaccess element 306 for accessing an area of an aneurysm, and anocclusion element 310, for providing occlusion means to the ostium of the aneurysm.Distal end 304 ofdevice 300 includes an access elementdistal portion 307 and an occlusion elementdistal portion 340, wherein occlusion elementdistal portion 340 includes aballoon 316 having a balloonproximal end 342 and a balloondistal end 344. In the embodiment shown inFIGS. 3A and 3B ,access element 306 is an elongated element extending distally past balloonproximal end 342, and includes anaccess lumen 308 therethrough.Access element 306 is comprised of an elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively,distal portion 207 of access element 206 includes a spring-element that provides pre-shaping. Aradiopaque access marker 325 is positioned ondistal portion 307 ofaccess element 306.Proximal end 302 ofshaft 303 has a larger diameter thandistal portion 304 ofshaft 303 and thanaccess element 306.Occlusion element 310 is aballoon 316 positioned atdistal end 304 ofshaft 303. Bothaccess lumen 308 andballoon 316 are in communication withshaft 303, and may be accessed via a sharedhub 317.Balloon 316 is shown in an inflated state inFIG. 3A and in a deflated state inFIG. 3B . In one embodiment, adivider 309 partially separatesballoon 316 fromshaft 303, allowing fluid flow but not allowing transfer of denser materials. This configuration allows for a microcatheter having an outer diameter which is approximately equal to an inner diameter ofaccess element 306 to be introduced throughaccess lumen 308, effectively sealingaccess element 306. Once the microcatheter is in place in the aneurysm, inflation fluid can be introduced throughshaft 303, and will flow directly intoballoon 316. Additionalradiopaque markers 324 are positioned alongocclusion element 310 and/orshaft 303. - A distal connecting
element 314 is positioned at a distal end ofdevice 300, and may be attached toballoon 316. Alternatively, distal connectingelement 314 may be attached to a distal tip, distal toballoon 316. As shown inFIG. 3A ,access element 306 is pre-shaped at an angle to alongitudinal axis 346 ofdevice 300, whereinlongitudinal axis 346 is defined by an imaginary line connectingdistal end 304 andproximal end 302 ofshaft 303. The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. - As shown in
FIG. 3B ,pre-shaped access element 306 can be forcibly aligned withlongitudinal axis 346 ofdevice 300 by placing aguidewire 318 therethrough andfurther positioning guidewire 318 through distal connectingelement 314. This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. In one embodiment,access element 306 acts as a microcatheter for providing treatment coils. In an alternative embodiment,access element 306 acts as a conduit for a separate microcatheter placed therein. - Reference is now made to
FIG. 3C , which is a cross-section illustration of section C-C showingaccess lumen 308 andshaft 303. The cross-sectional shape ofshaft 303 may be approximately circular, as shown inFIG. 3C , or may be elliptical, may assume a figure-eight configuration, or may be any other suitable shape or configuration. In some embodiments, acore wire 322 is positioned throughdevice 300 to provide stiffness. Additionally, stiffness ofproximal end 302 ofshaft 303 may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability. - Reference is now made to
FIGS. 4A and 4B , which are schematic illustrations of adevice 400 in accordance with embodiments of the present invention, shown in a pre-deployed state and in a deployed state, respectively.Device 400 includes ashaft 403 having aproximal end 402 and adistal end 404.Device 400 includes anaccess element 406 for accessing an area of an aneurysm, and anocclusion element 410, for providing occlusion means to the ostium of the aneurysm. In the embodiment shown inFIGS. 4A and 4B ,access element 406 is an elongated element extending from anaccess port 411 along a body ofdevice 400 todistal end 404 ofshaft 403, and includes anaccess lumen 408 therethrough. Aradiopaque access marker 425 is positioned on a distal portion ofaccess element 406.Occlusion element 410 is an elongated element extending fromproximal end 402 ofshaft 403 to a location proximal todistal end 404 ofshaft 403.Occlusion element 410 includes aballoon 416 having adistal portion 417 and aproximal portion 418.Distal portion 417 has a different compliance thanproximal portion 418. The difference in compliance may be provided by the use of different materials fordistal portion 417 andproximal portion 418. Alternatively, the same material may be used, but with different durometers or thicknesses. Any other known method of providing an object with two different compliances may be used. In a preferred embodiment,distal portion 417 has a lower compliance thanproximal portion 418. In other embodiments,distal portion 417 has a higher compliance thanproximal portion 418.Balloon 416 is shown in a deflated state inFIG. 4A and in an inflated state inFIG. 4B . Aninflation lumen 412 provides fluid communication between aninflation port 415 atproximal end 402 ofshaft 403 andballoon 416. - While generally not recommended for endovascular aneurysm treatment, there may be some cases where the use of a stent may be beneficial. It should be readily apparent that a stent may be positioned at a distal end of any of the devices described above, and that
balloon - In some embodiments, a fixed wire is added to the distal end of
balloon - Reference is now made to
FIGS. 5A , 5B, 5C and 5D, which are schematic illustrations of adevice 500 in accordance with embodiments of the present invention. In a first embodiment, shown inFIG. 5A in a deployed state and inFIG. 5B in a pre-deployed state,device 500 includes ashaft 503 having aproximal end 502 and adistal portion 504.Device 500 includes anaccess element 506 for accessing an area of an aneurysm, and anocclusion element 510, for providing occlusion means to the aneurysm.Access element 506 is an elongated element extending fromproximal end 502 ofshaft 503 todistal portion 504 ofshaft 503, and includes anaccess lumen 508 therethrough. Adistal portion 507 ofaccess element 506 is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively,distal portion 507 ofaccess element 506 includes a spring-element that provides pre-shaping. - A
radiopaque access marker 525 is positioned ondistal portion 507 ofaccess element 506.Occlusion element 510 is also an elongated element positioned alongside and attached to accesselement 506, and extending fromproximal end 502 ofshaft 503 todistal portion 504 ofshaft 503.Occlusion element 510 includes anocclusion lumen 512 for introduction of occlusion material, such as a coil, therethrough. Adistal portion 513 ofocclusion element 510 is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively,distal portion 513 ofocclusion element 510 includes a spring-element that provides pre-shaping. Additionalradiopaque markers 524 may be positioned alongocclusion element 510. In one embodiment,shaft 503 is a dual lumen shaft having anaccess lumen 508 and anocclusion lumen 512. -
Distal portions device 500, wherein the longitudinal axis is defined by an imaginary line connectingdistal portion 504 andproximal end 502 ofshaft 503. The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees.Proximal end 502 ofshaft 503 includes anaccess hub 517 for introduction of a material or object throughaccess lumen 508, and anocclusion hub 519 for introduction of a material or object throughocclusion lumen 512. -
Device 500 is shown in a pre-deployed position inFIG. 5B , wherein aguidewire 518 positioned throughocclusion lumen 512 forcibly alignsdistal portions device 500. Alternatively, guidewire 518 may be positioned throughaccess lumen 508. This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. Upon removal ofguidewire 518, distal ends 507 and 513 assume their pre-shaped configuration. - In an alternative embodiment, shown in
FIGS. 5C and 5D , a distal connectingelement 514 is positioned at distal end ofocclusion element 510. In this embodiment, an additionalradiopaque marker 524 may be positioned on distal connectingelement 514. In this embodiment,pre-shaped access element 506 andpre-shaped occlusion element 510 can be forcibly aligned with the longitudinal axis ofdevice 500 by placing aguidewire 518 throughaccess lumen 508 andfurther positioning guidewire 518 through distal connectingelement 514. - Reference is now made to
FIGS. 6A-6D , which are schematic illustrations of the steps of a method of usingdevice 100 to treat an aneurysm. Although the figures are shown and described with respect todevice 100, the method for usingdevice 200 may be the same as fordevice 100. As shown inFIG. 6A ,device 100 is introduced over aguidewire 118 into amain vessel 132 to an area of ananeurysm 134.Device 100 is in its unexpanded state, withdistal portion 107 ofaccess element 106 held in an aligned position withdevice 100 viaguidewire 118 placed throughaccess element 106 and distal connectingelement 114. As shown inFIG. 6B , guidewire 118 is retracted proximally, releasingguidewire 118 from distal connectingelement 114, and causingdistal portion 107 ofaccess element 106 to assume its pre-shaped configuration.Distal portion 107 ofaccess element 106 is positioned withinaneurysm 134.Markers FIG. 6C ,access element 106 is positioned withinaneurysm 134, andballoon 116 is expanded—blocking the neck or ostium ofaneurysm 134. As shown inFIG. 6D , acoil 136 is then introduced throughaccess lumen 108 and intoaneurysm 134, in accordance with methods known in the art. Alternatively, a microcatheter is then introduced throughaccess lumen 108, andcoil 136 is delivered through the microcatheter.Balloon 116 can be inflated and deflated several times during the procedure so as to alternate between allowing normal blood passage throughmain vessel 132, and keeping the ostium ofaneurysm 134 blocked untilcoil 136 is set. Oncecoil 136 is set,balloon 116 is deflated, anddevice 100 is removed from the vessel. - Reference is now made to
FIGS. 7A-7D , which are schematic illustrations of the steps of a method of usingdevice 300 to treat an aneurysm. As shown inFIG. 7A ,device 300 is introduced over aguidewire 318 into amain vessel 132 to an area of ananeurysm 134.Device 300 is in its unexpanded state, withaccess element 306 held in an aligned position withdevice 300 viaguidewire 318 placed throughaccess element 306 and distal connectingelement 314. As shown inFIG. 7B , guidewire 318 is retracted proximally, releasingguidewire 318 from distal connectingelement 314, and causingdistal portion 307 ofaccess element 306 to assume its pre-shaped configuration.Distal portion 307 ofaccess element 306 is positioned withinaneurysm 134. Markers are used for positioning, as will be described in further detail hereinbelow. As shown inFIG. 7C ,distal portion 307 ofaccess element 306 is positioned withinaneurysm 134.Microcatheter 320 is then positioned inaccess lumen 308.Microcatheter 320 effectively sealsaccess element 306, allowing for inflation fluid to reachballoon 316.Balloon 316 is then expanded, blocking the neck or ostium ofaneurysm 134. As shown inFIG. 7D , acoil 336 is then introduced throughmicrocatheter 320 and intoaneurysm 134, in accordance with methods known in the art.Balloon 316 can be inflated and deflated several times during the procedure so as to alternate between allowing normal blood passage throughmain vessel 132, and keeping the ostium ofaneurysm 134 blocked untilcoil 336 is set. Oncecoil 336 is set,balloon 316 is deflated, anddevice 300 is removed from the vessel. - Reference is now made to
FIGS. 8A-8D , which are schematic illustrations of the steps of a method of usingdevice 500 to treat an aneurysm. Although the figures are shown and described with respect to one embodiment ofdevice 500, the method for using other embodiments ofdevice 500 may be the same as the method depicted inFIGS. 8A-8D . As shown inFIG. 8A ,device 500 is introduced over aguidewire 518 into amain vessel 132 to an area of ananeurysm 134.Device 500 is in its undeployed state, withaccess element 506 andocclusion element 510 held in an aligned position viaguidewire 518 placed throughaccess element 506 and distal connectingelement 514. As shown inFIG. 8B , guidewire 518 is retracted proximally, releasingguidewire 518 from distal connectingelement 514, and causingdistal portion 507 ofaccess element 506 anddistal portion 513 ofocclusion element 510 to assume their pre-shaped configurations.Distal portion 507 ofaccess element 506 anddistal portion 513 ofocclusion element 510 are positioned withinaneurysm 134.Markers FIG. 8C , a blockingcoil 535 is introduced throughocclusion lumen 512 and intoaneurysm 134—blocking the neck or ostium ofaneurysm 134. As shown inFIG. 8D , one ormore coils 136 are then introduced throughaccess lumen 508 and intoaneurysm 134, in accordance with methods known in the art. Aftercoils 136 are delivered intoaneurysm 134 and detached, and satisfactory filling of the aneurysm is confirmed, blockingcoil 535 is detached. Detachment ofcoils 136 and blockingcoil 535 is achieved in accordance with methods known in the art. Alternatively, a microcatheter is introduced throughocclusion lumen 512 to deliver blockingcoil 535, and a microcatheter is introduced throughaccess lumen 108 to delivercoils 136. This method alleviates the long occlusion time or potential vessel damage sometimes associated with the use of balloons for occlusion. - Reference is now made to
FIGS. 9A-9C , which are schematic illustrations of a method of usingdevice 100 to treat an aneurysm at a Y-bifurcation, such as a vertebrobasilar junction. In this type of vessel, ananeurysm 234 may be positioned just opposite amain vessel 232, and must be accessed head-on rather than from an angle. Although the method is shown fordevice 100, it should be readily apparent that any of the devices in accordance with the various embodiments may be similarly used. As shown inFIG. 9A ,device 100 is introduced over aguidewire 118 throughmain vessel 232. As shown inFIG. 9B ,access element 106 is positioned inaneurysm 134.Balloon 116 is then inflated, as shown inFIG. 9C . In some instances,balloon 116 is compliant enough to block the ostium on its own. In other instances, it may be useful to introduce a second device withballoon 116 positioned over the remainder ofostium 134. Once the ostium is blocked,coil 136 is introduced intoaneurysm 134, as described above with respect toFIGS. 6A-6D , 7A-7D and 8A-8D. - Reference is now made to
FIGS. 10A-10C , which are schematic illustrations of a method of usingdevice 400 to treat an aneurysm at a Y-bifurcation, such as a vertebrobasilar junction. In this type of vessel, ananeurysm 234 may be positioned just opposite amain vessel 232, and must be accessed head-on rather than from an angle. As shown inFIG. 10A ,device 400 is introduced over aguidewire 419 throughmain vessel 232. As shown inFIG. 10B ,access element 406 is positioned inaneurysm 134, andballoon 416 is inflated. The high compliance ofproximal portion 418 causesproximal portion 417 to be inflated over a wide area, causing the ostium to be substantially blocked. The low compliance ofdistal portion 417 preventsballoon 416 from expanding intoaneurysm 234. Once the ostium is blocked,coil 136 is introduced intoaneurysm 234, as described above with respect toFIGS. 6A-6D , 7A-7D, 8A-8D, and 9A-9D. - Reference is now made to
FIGS. 11A , 11B and 11C, which are illustrations of several views of marker positioning.Marker 125, positioned ondistal portion 107 ofaccess element 106, andmarkers 124, positioned along the longitudinal axis ofdevice 100, together provide an indication of positioning and location. It should be readily apparent that similar configurations are provided in the alternative embodiments ofdevice FIG. 11A ,markers 124 form a relatively straight line, whilemarker 125 is slightly off the line formed bymarkers 124. This indicates translational positioning ofdevice 100 prior to deployment. When thedistal portion 107 ofaccess element 106 ofdevice 100 is released, it assumes its pre-shaped configuration, andmarker 125 moves to a position which is further off the line formed bymarkers 124, as shown inFIG. 11B . If positioning is inaccurate,marker 125 appears at a side opposite the aneurysm, as shown inFIG. 11C . Thus, if a user views the view shown inFIG. 11C or a similar view, the user can then rotatedevice 100 until it is in the correct position as indicated by the position ofmarkers FIG. 11B . This specific configuration of markers allows for proper alignment and positioning within the vessel. - In additional embodiments of the invention,
access element access element occlusion element - While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.
Claims (27)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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US11/685,807 US8221447B2 (en) | 2006-03-14 | 2007-03-14 | Aneurysm coil delivery system |
US13/467,063 US8361106B2 (en) | 2006-03-14 | 2012-05-09 | Aneurysm coil delivery system |
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US78172706P | 2006-03-14 | 2006-03-14 | |
US11/685,807 US8221447B2 (en) | 2006-03-14 | 2007-03-14 | Aneurysm coil delivery system |
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US13/467,063 Division US8361106B2 (en) | 2006-03-14 | 2012-05-09 | Aneurysm coil delivery system |
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US13/467,063 Expired - Fee Related US8361106B2 (en) | 2006-03-14 | 2012-05-09 | Aneurysm coil delivery system |
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EP (1) | EP2004270B1 (en) |
JP (1) | JP5171804B2 (en) |
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Also Published As
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JP2009533077A (en) | 2009-09-17 |
US8221447B2 (en) | 2012-07-17 |
CN102813541A (en) | 2012-12-12 |
US8361106B2 (en) | 2013-01-29 |
WO2007105217A3 (en) | 2009-04-09 |
CN101557854B (en) | 2012-08-15 |
US20120283764A1 (en) | 2012-11-08 |
JP5171804B2 (en) | 2013-03-27 |
HK1137950A1 (en) | 2010-08-13 |
EP2004270A4 (en) | 2010-03-03 |
CN101557854A (en) | 2009-10-14 |
EP2004270B1 (en) | 2016-11-02 |
EP2004270A2 (en) | 2008-12-24 |
WO2007105217A2 (en) | 2007-09-20 |
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